An observational study in Skin Cancer, Skin Condition and Skin Diseases, sponsored by Enspectra Health. Completed at 1 site in United States. Open to participants aged 2 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Enspectra Health · Observational
The overall objective of this study is to investigate the potential for the VIO System to display microscopic skin structure in people of different age, sex, race, and skin health.
604 studies on the registry are indexed under Skin Neoplasms; 126 are open to participants now.
This study's enrollment of 122 is below the median of 200 across 157 observational studies indexed under Skin Neoplasms.
Browse Skin Neoplasms studies →Enspectra Health is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy subjects, volunteers as well subjects with suspected skin condition recruited from dermatology clinics
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Has a temporary or permanent electrical implanted medical device
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: VIO System
To investigate the potential for the VIO System to display microscopic skin structure in people of different age, sex, race, and skin health
VIO System Imaging Performance
Quantify imaging performance in various types of skin, which may include estimated in vivo resolution and imaging depth. Various types of skin includes skin of different people as well as skin in different locations on the body, and skin with skin disease, including basal cell carcinoma. VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device imaging performance (acceptable/not acceptable) was assessed through engineering expert review of VIO images. The engineering expert review determined whether images were of consistent quality.
Time frame: 3 hours
VIO System Image Quality
Qualitatively evaluate image quality and interpretability by physicians trained in dermatopathology as a function of skin type. VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device image quality (acceptable/not acceptable) was assessed through clinical expert review of VIO images. The clinical expert review determined whether VIO images could be interpreted by physicians trained in dermatopathology.
Time frame: 3 hours
| Milestone | VIO Imaging |
|---|---|
| Started | 122 |
| Completed | 122 |
| Not completed | 0 |
Quantify imaging performance in various types of skin, which may include estimated in vivo resolution and imaging depth. Various types of skin includes skin of different people as well as skin in different locations on the body, and skin with skin disease, including basal cell carcinoma. VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device imaging performance (acceptable/not acceptable) was assessed through engineering expert review of VIO images. The engineering expert review determined whether images were of consistent quality.
| # participants with acceptable images | VIO Imaging |
|---|---|
| VIO System Imaging Performance | 122 |
Qualitatively evaluate image quality and interpretability by physicians trained in dermatopathology as a function of skin type. VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device image quality (acceptable/not acceptable) was assessed through clinical expert review of VIO images. The clinical expert review determined whether VIO images could be interpreted by physicians trained in dermatopathology.
| # participants with acceptable images | VIO Imaging |
|---|---|
| VIO System Image Quality | 122 |
Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VIO Imaging | 0/122 (0%) | 0/122 (0%) | 0/122 (0%) |
| Age, Continuous(years) | VIO Imaging |
|---|---|
| Mean | 47 ± 19 |
| Sex: Female, Male(Participants) | VIO Imaging |
|---|---|
| Female | 47 |
| Male | 75 |
| Ethnicity (NIH/OMB)(Participants) | VIO Imaging |
|---|---|
| Hispanic or Latino | 10 |
| Not Hispanic or Latino | 111 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | VIO Imaging |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 20 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 8 |
| White | 84 |
| More than one race | 9 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | VIO Imaging |
|---|---|
| United States | 122 |
| Fitzpatrick Skin Type(Participants) | VIO Imaging |
|---|---|
| Type I | 6 |
| Type II | 30 |
| Type III | 46 |
| Type IV | 25 |
| Type V | 5 |
| Type VI | 1 |
| Unknown | 9 |
| Skin Health(Participants) | VIO Imaging |
|---|---|
| Healthy | 90 |
| Suspected or known skin diseases | 32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Enspectra Health